The performance characteristics of this test were determined by the
University of Iowa Microbiology and Molecular Pathology Laboratory.
It has not been cleared or approved by the U.S. Food and Drug
Administration (FDA). The FDA has determined that such clearance or
approval is not necessary. This test is for clinical purposes. It
should not be regarded as investigational or for research. The
laboratory is certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) as qualified to perform high complexity
clinical laboratory testing.